Senseonics submits clinical study protocol to UK and German regulatory agencies

Sensors for Medicine and Science Inc, the Maryland based medical device company developing and commercialising the first fully implantable, long-term CGM ( continuous glucose monitoring) system, has renamed itself Senseonics. "The new Senseonics name really captures the essence of what we're about and what makes us unique," said president and CEO, Tim Goodnow, PhD. "The name combines sense (to detect), eon (long time) and -ics (suffix to denote body of knowledge) to signal our unequivocal focus on continuous glucose sensors designed for accurate, long-term wear by people with diabetes.  Our first generation sensor, currently in clinical studies, is targeted to last for up to six months of continuous wear." The company also announced it has submitted its pivotal clinical study protocol to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in Germany. The study PRECISE (Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) has as its objective to evaluate accuracy of the Senseonics CGM system over 180 days. PRECISE requires clinical participants with diabetes to use the glucose sensor in the arm and wear the external receiver to obtain continuous glucose readings during the 180-day study duration. The study will also evaluate safety of the Senseonics CGM system usage during in-clinic and home wear. "All the study investigators are very much looking forward to proceeding with this first large study of a long-term implantable glucose sensor," said primary investigator Dr. Roman Hovorka, from the University of Cambridge, UK.   "This has the potential to be an important technology to help our patients better manage their diabetes." The PRECISE study will be conducted in three clinical sites in Germany and two in the U.K.   Enrolment in the trial will include up to 50 diabetic subjects and builds upon previous clinical experience, which demonstrated high accuracy performance for the first time for an implanted biosensor. "The filing of the PRECISE pivotal study application represents an important milestone in the development of our glucose sensing system, and the study will allow us to gather clinical data for European regulatory approval," said Goodnow.  A successful execution of the PRECISE study is expected to support an application for a CE mark in Europe.   Senseonics